Validation Engineer

Validation Engineer

We are seeking an experienced Validation Engineer to join our Quality Assurance and Validation team. The successful candidate will play a key role in the validation and qualification of equipment, utilities, processes, and software systems in compliance with cGMP, FDA, European GMP, and GAMP standards.

This position requires strong technical expertise in aseptic processing validation, autoclave validation, HVAC systems, and clean utility validation within a pharmaceutical or biotechnology manufacturing environment.

Key Responsibilities

• Participate actively in the site Validation Program and broader Quality Assurance activities.
• Coordinate, direct, and execute validation and qualification activities for equipment, utilities, processes, and software systems.
• Generate, maintain, and execute Validation Plans, protocols, schedules, and final reports in accordance with cGMP requirements.
• Support validation investigations, deviation management, and implementation of corrective and preventive actions (CAPAs).
• Supervise vendors and contractors performing validation activities on site.
• Execute and support qualification and requalification activities for:
  • Autoclaves
  • Parts Washers
  • Lyophilizers (Lyo)
  • CIP/SIP Systems
  • VHP Systems
  • Temperature Mapping Studies
• Perform aseptic processing validation activities including media fills and VHP validation execution.
• Support HVAC validation activities and environmental qualification programs.
• Create, review, and approve validation and qualification documentation.
• Manage validation-related change controls, exception events, and documentation processes.
• Ensure all validation activities are documented in compliance with cGMP and company procedures.
• Deliver cross-training within the validation team and support onboarding/training of new team members.
• Participate in continuous improvement initiatives relating to manufacturing, quality, safety, and training systems.
• Coordinate team activities to maximize efficiency and compliance.
• Communicate effectively with peers, cross-functional teams, and management regarding validation activities, issues, and escalation of concerns where necessary.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
• Minimum 5 years’ experience in validation within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Proven experience in:
  • Autoclave validation execution
  • Aseptic processing validation
  • Media fill execution
  • VHP validation
  • HVAC validation
• Strong understanding of:
  • FDA and European cGMP regulations
  • GAMP guidelines
  • Validation lifecycle principles
  • Change control and deviation management
• Experience generating and executing validation protocols and reports.
• Excellent documentation, communication, and organizational skills.
• Ability to work independently and collaboratively within cross-functional teams

Desirable Experience

• Experience with sterile manufacturing environments.
• Knowledge of cleanroom qualification and environmental monitoring systems.
• Experience supporting audits and regulatory inspections.
• Familiarity with computerized system validation (CSV) and data integrity principles

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose